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BRPI0616374B8 - form i of the phosphate salt of a 2-indolinone substituted pyrrole compound, pharmaceutical composition, uses and method of preparation of form i - Google Patents

form i of the phosphate salt of a 2-indolinone substituted pyrrole compound, pharmaceutical composition, uses and method of preparation of form i

Info

Publication number
BRPI0616374B8
BRPI0616374B8 BRPI0616374A BRPI0616374A BRPI0616374B8 BR PI0616374 B8 BRPI0616374 B8 BR PI0616374B8 BR PI0616374 A BRPI0616374 A BR PI0616374A BR PI0616374 A BRPI0616374 A BR PI0616374A BR PI0616374 B8 BRPI0616374 B8 BR PI0616374B8
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
indolinone
phosphate salt
polymorphs
preparation
Prior art date
Application number
BRPI0616374A
Other languages
Portuguese (pt)
Inventor
Calvin Sun Changquan
Hawley Michael
Original Assignee
Pah Usa 15 Llc
Pfizer Prod Inc
Zoetis P Llc
Zoetis Services Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pah Usa 15 Llc, Pfizer Prod Inc, Zoetis P Llc, Zoetis Services Llc filed Critical Pah Usa 15 Llc
Publication of BRPI0616374A2 publication Critical patent/BRPI0616374A2/en
Publication of BRPI0616374B1 publication Critical patent/BRPI0616374B1/en
Publication of BRPI0616374B8 publication Critical patent/BRPI0616374B8/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D403/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
    • C07D403/06Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D403/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/14Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing three or more hetero rings

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Rheumatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oncology (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Endocrinology (AREA)
  • Transplantation (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

formas de sal sólido para um pirrol substituído 2-indolinona, composição farmacêutica compreendendo as mesmas, método para modulação de atividade catalítica de proteína quinase, proteína quinase, métodos para preparação de cristais e de polimorfos e uso. a presente invenção refere-se a formas de sal sólido de um composto 3-pirrol substituído 2-indolinona, (2-pirrolidina-1-ii-etil)-amida de ácido 5-[5-flúor-2-oxo-1 ,2-di-hidro-indol-(3z)-ilidenometil]-2 ,4-dimetil-1h-pirrol-3- carboxílico. também refere-se a polimorfos do sal fosfato da amida. a invenção ainda refere-se ao uso dos sais e polimorfos no tratamento de distúrbios relacionados com proteína quinase.solid salt forms for a 2-indolinone substituted pyrrole, pharmaceutical composition comprising the same, method for modulating protein kinase catalytic activity, protein kinase, methods for preparing crystals and polymorphs and use. The present invention relates to solid salt forms of a 3-pyrrole substituted 2-indolinone compound, 5-[5-fluoro-2-oxo-1, acid (2-pyrrolidine-1-h-ethyl)-amide, 2-dihydro-indole-(3z)-ylidenemethyl]-2,4-dimethyl-1h-pyrrole-3-carboxylic acid. also refers to polymorphs of the phosphate salt of the amide. the invention further relates to the use of the salts and polymorphs in the treatment of protein kinase related disorders.

BRPI0616374A 2005-09-19 2006-09-08 form i of the phosphate salt of a 2-indolinone substituted pyrrole compound, pharmaceutical composition, uses and method of preparation of form i BRPI0616374B8 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US71858605P 2005-09-19 2005-09-19
US60/718,586 2005-09-19
PCT/IB2006/002506 WO2007034272A1 (en) 2005-09-19 2006-09-08 Solid salt forms of a pyrrole substituted 2-indolinone

Publications (3)

Publication Number Publication Date
BRPI0616374A2 BRPI0616374A2 (en) 2011-06-21
BRPI0616374B1 BRPI0616374B1 (en) 2020-05-12
BRPI0616374B8 true BRPI0616374B8 (en) 2021-05-25

Family

ID=37626412

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0616374A BRPI0616374B8 (en) 2005-09-19 2006-09-08 form i of the phosphate salt of a 2-indolinone substituted pyrrole compound, pharmaceutical composition, uses and method of preparation of form i

Country Status (24)

Country Link
US (3) US20080275101A1 (en)
EP (2) EP1928858B1 (en)
JP (2) JP4519114B2 (en)
KR (1) KR101050906B1 (en)
CN (2) CN103601720B (en)
AR (1) AR056521A1 (en)
AU (1) AU2006293644B2 (en)
BR (1) BRPI0616374B8 (en)
CA (1) CA2621569C (en)
CY (1) CY1109326T1 (en)
DE (1) DE602006008015D1 (en)
DK (1) DK1928858T3 (en)
ES (1) ES2328407T3 (en)
IL (1) IL189590A0 (en)
MX (1) MX2008002415A (en)
NO (1) NO20080866L (en)
NZ (1) NZ566033A (en)
PL (1) PL1928858T3 (en)
PT (1) PT1928858E (en)
RU (1) RU2399619C2 (en)
SI (1) SI1928858T1 (en)
TW (1) TWI310766B (en)
WO (1) WO2007034272A1 (en)
ZA (1) ZA200801431B (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK1928858T3 (en) 2005-09-19 2009-10-26 Pfizer Prod Inc Solid salt forms of a pyrrole-substituted 2-indolinone
US20100189788A1 (en) 2009-01-23 2010-07-29 Teva Pharmaceutical Industries, Ltd. Delayed release rasagiline base formulation
CN102858739A (en) 2010-03-10 2013-01-02 斯索恩有限公司 A process for amidation of pyrrole carboxylate compounds

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2155187C2 (en) * 1992-08-06 2000-08-27 Варнер-Ламберт Компани Derivatives of indole, their tautomers, mixtures of their isomers or separate isomers and pharmaceutically acceptable salts, pharmaceutical composition showing antitumor or inhibiting protein tyrosine kinase activity and method of inhibition of protein tyrosine kinase-depending disease or control of aberrant growth of mammalian or human cells
US6574293B1 (en) 1998-10-28 2003-06-03 Ericsson Inc. Receivers and methods for reducing interference in radio communications
PT1255536E (en) * 1999-12-22 2006-09-29 Sugen Inc DERIVATIVES OF INDOLINONE FOR THE MODULATION OF TYROSINE PROTEIN CINASE TYPE C-KIT
PT1255752E (en) * 2000-02-15 2007-10-17 Pharmacia & Upjohn Co Llc Pyrrole substituted 2-indolinone protein kinase inhibitors
WO2002081466A1 (en) * 2001-04-09 2002-10-17 Sugen, Inc. Prodrugs of 3-(pyrrol-2-ylmethylidene)-2-indolinone derivatives
DK3168218T3 (en) 2001-08-15 2019-01-14 Pharmacia & Upjohn Co Llc Crystalline comprising an L-malic acid salt of N- [2- (DIETHYLAMINO) ETHYL] -5 - [(5-FLUOR-1,2-DIHYDRO-2-OXO-3H-INDOL-3-YLIDE) METHYL] -2,4 -DIMETHYL-1H-PYRROL-3-CARBOXAMIDE FOR USE AS A MEDICINE
MXPA04006992A (en) * 2002-02-15 2004-11-10 Upjohn Co Process for preparing indolinone derivatives.
US7452913B2 (en) * 2003-02-24 2008-11-18 Pharmacia & Upjohn Company Polymorphs of pyrrole substituted 2-indolinone protein kinase inhibitors
US20040209937A1 (en) * 2003-02-24 2004-10-21 Sugen, Inc. Treatment of excessive osteolysis with indolinone compounds
US20060009510A1 (en) * 2004-07-09 2006-01-12 Pharmacia & Upjohn Company Llc Method of synthesizing indolinone compounds
DK1928858T3 (en) 2005-09-19 2009-10-26 Pfizer Prod Inc Solid salt forms of a pyrrole-substituted 2-indolinone

Also Published As

Publication number Publication date
DE602006008015D1 (en) 2009-09-03
JP2007084540A (en) 2007-04-05
CN103601720A (en) 2014-02-26
AU2006293644A1 (en) 2007-03-29
RU2008109959A (en) 2009-10-27
NO20080866L (en) 2008-03-13
TW200745093A (en) 2007-12-16
IL189590A0 (en) 2008-08-07
EP1928858A1 (en) 2008-06-11
BRPI0616374B1 (en) 2020-05-12
CN101287724A (en) 2008-10-15
US20080275101A1 (en) 2008-11-06
PT1928858E (en) 2009-09-17
PL1928858T3 (en) 2009-12-31
ZA200801431B (en) 2009-07-29
EP2112148A1 (en) 2009-10-28
KR20080037093A (en) 2008-04-29
AR056521A1 (en) 2007-10-10
ES2328407T3 (en) 2009-11-12
US9290479B2 (en) 2016-03-22
CN103601720B (en) 2016-08-10
EP1928858B1 (en) 2009-07-22
AU2006293644B2 (en) 2012-05-31
SI1928858T1 (en) 2009-10-31
BRPI0616374A2 (en) 2011-06-21
CA2621569A1 (en) 2007-03-29
US20150158849A1 (en) 2015-06-11
HK1125101A1 (en) 2009-07-31
NZ566033A (en) 2011-04-29
CN101287724B (en) 2013-11-06
DK1928858T3 (en) 2009-10-26
CA2621569C (en) 2010-10-19
CY1109326T1 (en) 2014-07-02
JP4519114B2 (en) 2010-08-04
TWI310766B (en) 2009-06-11
MX2008002415A (en) 2008-03-27
WO2007034272A1 (en) 2007-03-29
JP2010090152A (en) 2010-04-22
US8987320B2 (en) 2015-03-24
US20120142749A1 (en) 2012-06-07
KR101050906B1 (en) 2011-07-20
RU2399619C2 (en) 2010-09-20

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Legal Events

Date Code Title Description
B06G Technical and formal requirements: other requirements [chapter 6.7 patent gazette]

Free format text: APRESENTE O DEPOSITANTE NOVAS VIAS DAS FOLHAS DOS DESENHOS, SEM CORES , CONFORME DETERMINA ATO NORMATIVO NO 127 DE 05/03/1997 ITEM 15.1.4.1B.

B25A Requested transfer of rights approved

Owner name: PAH USA 15 LLC (US)

B25D Requested change of name of applicant approved

Owner name: ZOETIS P LLC (US)

B25A Requested transfer of rights approved

Owner name: ZOETIS SERVICES LLC (US)

B25G Requested change of headquarter approved

Owner name: ZOETIS SERVICES LLC (US)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 12/05/2020, OBSERVADAS AS CONDICOES LEGAIS.

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Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 08/09/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF